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Study of Ruxolitinib in Colorectal Cancer Patients

NCT02119676 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2018-02-13

Study results available
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Summary

The purpose of this study was to determine if ruxolitinib, in combination with regorafenib, is safe and effective in the treatment of metastatic colorectal cancer.

Conditions

  • CRC (Colorectal Cancer)

Interventions

DRUG

Ruxolitinib

5 mg tablets to be administered by mouth Ruxolitinib 20 mg twice a day (BID) (Part 1) (NOTE: The starting dose for the randomized portion of study (Part 2) was 15 mg BID based on results from Part 1.)

DRUG

Regorafenib

Regorafenib 160mg once daily for the first 21 days of each 28-day cycle. (NOTE: Dose interruptions and modifications for regorafenib are expected when toxicities occur in which dose interruptions or modifications are appropriate.)

DRUG

Placebo

5 mg matching placebo tablets to be administered by mouth

Sponsors & Collaborators

Principal Investigators

  • Albert Assad · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-02-29
Completion
2016-12-31

Countries

  • United States
  • Australia
  • France
  • Germany
  • Israel
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02119676 on ClinicalTrials.gov